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Clinical Trials/NCT02394509
NCT02394509
Completed
Not Applicable

HOBSCOTCH Phase II: A Pragmatic Study of HOBSCOTCH in New England.

Dartmouth-Hitchcock Medical Center4 sites in 1 country106 target enrollmentMarch 2015
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
106
Locations
4
Primary Endpoint
Change in Quality of Life
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to determine the feasibility and efficacy of the home-based cognitive self-management program "HOBSCOTCH" delivered at four New England medical centers. It will test the long-term impact and cost-effectiveness of HOBSCOTCH, and whether it can be delivered from a distance utilizing e-health tools for parts of the program.

Detailed Description

HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. HOBSCOTCH Phase II is a replication study of the original HOBSCOTCH study, designed to translate the findings of HOBSCOTCH into a real world setting. This is a multi-center study, with the HOBSCOTCH intervention being implemented at four epilepsy clinics in New England.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
September 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Barbara Jobst

Staff Physician, Neurology

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Inclusion Criteria

  • Age 18-70
  • Confirmed diagnosis of epilepsy, with controlled or uncontrolled seizures
  • Subjective memory complaints
  • No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable
  • Telephone access

Exclusion Criteria

  • Subjects age 66-70 with a mention of a dementing illness in their medical record
  • Severe mental disability or estimated IQ less than 70
  • Significant visual impairment precluding reading or writing
  • No reliable telephone access

Outcomes

Primary Outcomes

Change in Quality of Life

Time Frame: Baseline and months: 3, 6, 9, 12, 15

We will be using Quality of Life in Epilepsy (QOLIE-31). This validated tool contains 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception

Change in Healthcare Utilization

Time Frame: Baseline and months: 3, 6, 9, 12, 15

We will be using the Healthcare Utilization in Epilepsy (HCU-E). This validated survey is concordant with billing data. It assesses seizure frequency and whether the subject had received any of the following services because of their epilepsy over the past 3 months: hospital ER services, general practice or family doctor visits, neurologist or epilepsy specialist visits, and overnight hospital inpatient stay.

Secondary Outcomes

  • Change in Depression(Baseline and months: 3, 6, 9, 12, 15)
  • Change in Cognition(Baseline and months: 3, 6, 9, 12, 15)
  • Change in Self-Management Practices(Baseline and months: 3, 6, 9, 12, 15)
  • Change in Cognitive Function(Baseline and months: 3, 6, 9, 12, 15)

Study Sites (4)

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